BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V200 VENTILATOR CONVERTED

    MDR report key: 1792281 · Received August 10, 2010

    Report

    Report Number
    2031642-2010-00218
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    July 4, 2010
    Report Date
    July 23, 2010
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE SERVICING THE VENTILATOR, THE MANUFACTURER'S SERVICE TECHNICIAN REPORTED THE VENTILATOR LOG HISTORY INDICATED THERE HAD BEEN AN OCCURRENCE OF A GAS SUPPLIES LOST: SAFETY VALVE OPEN ALARM. THERE WAS NO SUCH EVENT REPORTED BY THE CUSTOMER, AND THE CUSTOMER REPORTED THERE WAS NO PATIENT HARM REPORTED. IF THE VENTILATOR IS OPERATING, AND NO AIR FLOW IS DETECTED AND THE OXYGEN SOURCE IS NOT DETECTED BY THE OXYGEN PRESSURE SWITCH OR IS DISCONNECTED, THE VENTILATOR WILL ALARM AND THE SAFETY VALVE WILL OPEN. LOSS OF BOTH GAS SUPPLIES WILL AFFECT THE FUNCTION OF THE VENTILATOR. THE SERVICE TECHNICIAN DID NOT DUPLICATE A LOSS OF BOTH GAS SUPPLIES. PERFORMANCE VERIFICATION TESTING WAS COMPLETED AND TESTING PASSED TO OPERATING SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V200 VENTILATOR CONVERTED VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1